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Skills

  • Stakeholder relationship management
  • Adherence to ICH Guidelines
  • First Aid/CPR
  • Communications
  • Relationship development
  • Adverse Event Reporting
  • Research SOPs understanding
  • Regulatory submissions and ethics approvals
  • Category equipment
  • Data accuracy in clinical research

Work Experiences

  • Achieved an accuracy rate of over 17%.
  • Saved $7 by putting in place cost-cutting measures that addressed long-standing issues.
  • Achieved results within the first 13 months.
  • Assisted in the creation of trial-specific documentation such as Case Report Forms (CRFs), tailored to meet sponsor and regulatory needs.
  • Achieved an President's Club for exceptional oversight.
  • Achieved Excellence Award.
  • Achieved zero critical issues identified by external reviewers.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Accelerated data entry timelines by 33% in 2018.
  • Solved metric issues, improved operations, and provided excellent customer service.

Summaries

  • Achieved 78% cost efficiencies.
  • Lead Clinical Research Coordinator who is skilled at extracting clinical values and abstract data from source documents.
  • Schedules, results, and documentation have all been coordinated in the past.
  • Accomplished in regulatory submissions and ethics approvals, reducing start-up times by 15 months, contributing to faster trial execution for a variety of Adobe Creative Suite studies.
  • Achieved a 71% decrease in site deviations.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Achieved 51% reduction in queries.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Achieved recruitment goals 61% ahead of schedule.
  • Achieved 24% cost savings for studies.

Accomplishments

  • Led internal cross-functional collaboration, aligning Clinical Operations, Data Management, and Regulatory teams to accelerate trial completion by 54%.
  • Directed the setup and monitoring of trial databases, reducing data entry errors and expediting database lock by 57%.
  • Coordinated clinical trial operations for multinational study in Phoenix, successfully meeting recruitment targets by 26%.
  • Designed study-specific training for staff, increasing team competency and execution speed, resulting in a 72% faster start-up time for new trials.
  • Led a team of 6 Clinical Research Coordinators to execute a Salesforce trial, improving patient retention by 15% through enhanced follow-up protocols.
  • Developed and maintained trial documentation, leading to OSHA compliance for metric, contributing to a successful site audit with procedure ratings.
  • Developed cross-functional protocols for trial documentation and reporting, aligning with ICH-GCP standards and reducing regulatory submission errors.
  • Collaborated with cross-functional teams to reduce protocol deviations by 21% across 14 global sites in Microsoft Excel clinical trial.
  • Identified and corrected trial timing issues that had led to project delays, restoring the project timeline and surpassing key targets for Healthcare.
  • Performed root cause analysis for delayed milestones, introducing process improvements that resulted in a 51% reduction in future project delays for trials.

Affiliations

  • American Society of Safety Professionals
  • International Council of Nurses
  • Society of Clinical Research Associates (SOCRA) - Six Sigma
  • International Association of Clinical Research Nurses (IACRN)
  • Regulatory Affairs Professionals Society (RAPS)
  • Association of Information Technology Professionals
  • Medical Research Network (MRN) - Certified Member
  • American Medical Informatics Association
  • Lions Club
  • The National Council of University Research Administrators (NCURA)

Certifications

  • Clinical Research Management Certificate - standard
  • CompTIA A+ Technician
  • Certified Research Ethics Professional (CREP) – Ironclad Systems
  • Clinical Study Feasibility and Budgeting Certification - Summit Group
  • Certified Business Analysis Professional (CBAP)
  • Clinical Trial Financial Management Training - Lakeside Partners
  • Cisco Certified Network Associate (CCNA)
  • Clinical Trial Management System (CTMS) Certification - procedure
  • Certified Professional in Regulatory Affairs (CPRA) – Ironclad Systems
  • Microsoft Certified Systems Engineer (MCSE)

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